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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Westchester Medical Center 24-Jan-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

New York District

Food & Drug Administration

300 Pearl Street, Suite 100

Buffalo, NY 14202

January 24, 2002

WARNING LETTER NYK 2002-21

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

RE: Facility ID Number 146415

Terence A. S. Matalon, M.D.

Director and Chairman

Department of Radiology

Westchester Medical Center

95 Grasslands Road

Valhalla, New York 10595

Dear Dr. Matalon:

Your facility was inspected on November 19,200l by a representative of the New York State Department of helath acting on behalf of the Food and Drug Administration (FDA). This inspection revealed a serious regulatory problem involving the mammography at your facility.

Under a United States Federal law, the Mammography Quality Standards Act of 1992, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The inspection revealed the following Level 1 finding at

your facility:

  • The system to communicate results is not adequate because there is no system in place to provide timely lay summaries.

The specific problem noted above appeared on your MQSA Facility Inspection Report which was issued to your facility at the close of the inspection. This problem is identified as Level 1 because it identifies a failure to meet a significant MQSA requirement.

In a letter to our office dated November 19, 2001, you promised measures had been taken to correct this violation. However, during a follow up inspection on January 8, 2002, a New York State Department of Health inspector found that Dr. Gelfand had not signed the final reports of at least 30 patients. These patients, as well as their referring physicians, had not received a final report of their mammography examination within

the time frames specified and required by 21 CFR 900.12(c)(2) and (c)(3).

This condition represents a violation of the law, which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction, charging your facility for the cost of on-site monitoring, assessing civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with

MQSA standards, suspension or revocation of your facility? s FDA certificate, or obtaining a court injunction against further mammography.

It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days from the date that you receive this letter each step your facility is taking to correct this violation and to prevent the recurrence of similar violations. Please submit your response to the above issues to the attention of Lisa M. Utz, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street,

Suite 100, Buffalo, NY 14202, telephone (716) 551-4461 ext. 3117.

Finally, you should understand there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA?s requirements for mammography facilities

by contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, Maryland 21045-6057 (1-800-838-7715), or through the Internet at http://www.fda.gov.

Sincerely,

Jerome G. Woyshner

District Director